Novartis is to pay a $185 million fine to settle criminal allegations relating to off-label promotion of the epilepsy drug Trileptal.

While presenting its fourth quarter results, the Swiss major noted that since 2005, it has been cooperating with the US Attorney's Office for the Eastern District of Pennsylvania over the latter’s allegations of potential off-label marketing and promotion of Trileptal (oxcarbazepine), “as well as certain payments made to healthcare providers in connection with this medicine”. Now Novartis has entered into a plea agreement with the investigators, which is contingent on court approval, and “will plead guilty to a misdemeanour violation of the US Food Drug and Cosmetic Act” and pay the aforementioned fine.

Novartis added that in the fourth quarter, it increased provisions relating to the Trileptal probe by $318 million, noting that at the end of 2009, $397 million had been set aside for civil and criminal investigations and is currently negotiating with the Attorney’s Office to resolve the civil claims.

The Basel-based group went on to say that the same office is investigating marketing practices relating to Diovan (valsartan), Exforge (valsartan/amlodipine), Sandostatin (octreotide), Tekturna (aliskiren), and Zelnorm (tegaserod). The firm added that it is “unable to assess with reasonable certainty the outcome of the investigation related to these five products or the amounts, which could be material, that it might be required to pay to resolve this investigation".